Hip or Knee SurgeryPhase 4MxB Po01NCT01841567
Post Market Clinical Follow-up Study
A Phase 4 study testing Mepilex border post. op and Mepilex border post op in people with Hip or Knee Surgery, run by Molnlycke Health Care AB at 1 site in Germany.
Trial summary
The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip or Knee Surgery
- What is being tested?
- Mepilex border post. op and Mepilex border post op
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 years
- Have an expected total length of stay of 4 or more days
- Undergoing elective primary arthroplasty of the hip or knee
- Undergoing hip surgery with a standard access
- Give their written informed consent to participate
Who cannot join
- Dressing size does not fit the incision area
- Known allergy hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumour
- Fractures
- Wound at the surgical site prior to surgery
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- Neurological deficit of operated side
- Subject has documented skin disease at time of enrolment, as judged by the investigator
- Previously enrolled in the present investigation
- Subject included in other ongoing investigation at present, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty
The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).
- Conditions
- Hip or Knee Surgery
- Being tested
- Mepilex border post. op, Mepilex border post op
- Keywords
- hip, knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex border post. opDevice
Mepilex border post opDevice
| Study group | Role | What they receive |
|---|---|---|
| dressing | Other | Not described Receives: Device: Mepilex border post. op; Device: Mepilex border post op |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimize the Risk of the Development of Blistering.
Number of participants without blisters at study visit
Measured: 7 days
Secondary outcomes (4)
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery
Measured: 7 days
Comfort, Comformability, Acceptability of the Dressing
Measured: 7 days
Pain Evaluation
Measured: 7 days
Overall Cost Regarding Dressing Wear Time
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip or Knee SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kourosh Zarghooni, Dr. Med, Principal investigator, University Hospital Koln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841567
- Sponsor's protocol ID
- MxB Po01
- Acronym
- MxB Po01
- Status last verified
- Dec 2013
- First submitted
- 23 Apr 2013
- Last updated
- 30 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01841567
- Acronym / sponsor ID
- MxB Po01 / MxB Po01
- Conditions
- Hip or Knee Surgery
- Keywords
- hip, knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 30 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dressing | Other | Device: Mepilex border post. op, Device: Mepilex border post op |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 45 years
- Have an expected total length of stay of 4 or more days
- Undergoing elective primary arthroplasty of the hip or knee
- Undergoing hip surgery with a standard access
- Give their written informed consent to participate
Key exclusion criteria (10 listed)
- Dressing size does not fit the incision area
- Known allergy hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumour
- Fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex border post. op | Device | dressing |
| Mepilex border post op | Device | dressing |
Primary outcome
Minimize the Risk of the Development of Blistering.
Time frame: 7 days
Number of participants without blisters at study visit
4 secondary outcomes
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.
Time frame: 7 days
Comfort, Comformability, Acceptability of the Dressing
Time frame: 7 days
Pain Evaluation
Time frame: 7 days
Overall Cost Regarding Dressing Wear Time
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hip or Knee Surgery
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Evaluation of Choose to Move Replacement Ready (CTM-RR)
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CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kourosh Zarghooni, Dr. Med principal investigator
University Hospital Koln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepilex border post. op and Mepilex border post op in people with Hip or Knee Surgery, run by Molnlycke Health Care AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimize the Risk of the Development of Blistering. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.